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Codeine Syrup Scandal: NAFDAC Shuts Down Emzor, Peace Standard, Bioraj Pharmaceutical Companies

By Appolonia Adeyemi

Due to insufficient evidence gathered and apparent resistance to provide needed documents during an inspection carried out by officials of the National Agency for Food and Drug Administration and Control (NAFDAC), NAFDAC has shut down three companies – Peace Standard Pharmaceutical Limited,  Bioraj Pharmaceutical Limit and Emzor Pharmaceuticals Industry  Limited.

According to a statement issued from the office of the Director-General, NAFDAC, Prof. Mojisola Adeyeye on Monday, “This is to allow for a full and comprehensive investigation” into the activities of the three companies”

It will be recalled that the Federal Ministry of Health (FMOH) directed NAFDAC to ban with immediate effect further issuance of permits for the importation of codeine as an active pharmaceutical ingredient for cough preparations.  It followed a BBC documentary that allegedly implicated an official of Emzor selling a codeine cough syrup without a prescription.

While stating that the three companies would, therefore, remain closed, Adeyeye said the reopening of the manufacturing companies would depend on the level of cooperation that will be shown during the comprehensive investigation.”

Giving the genesis of the shutdown, Adeyeye said a day before the BBC documentary aired on April 30, 2018, she had a meeting with technical directors of NAFDAC where she outlined the steps to be taken to strengthen the weakness in the control of the manufacturing and distribution of codeine-containing medicines as demonstrated in the documentary.

 These include the NAFDAC immediately placing an embargo on the issuance of a permit to end users of the raw material (a control substance), effective May 1, 2018, NAFDAC immediately deploying officers from Inspection and Enforcement Directorate (I&E) to inspect the alleged companies, among other measures.

The director general also noted that the stakeholders involved in the production and regulation of codeine-containing products should hold a meeting as quickly as possible. “The stakeholders include Pharmaceutical Manufacturers Group of Manufacturers Association of Nigeria (PMG- MAN), Pharmacists Council of Nigeria (PCN), Pharmaceutical Society of Nigeria (PSN), NAFDAC, National Drug Law Enforcement Agency (NDLEA) and Association of Community Pharmacists of Nigeria (ACPN).”

(New Telegraph) 

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FG Bans Cough Syrup With Codeine |The Republican News

The Federal Ministry of Health has directed the National Agency for Food and Drug Administration and Control (NAFDAC) to ban with immediate effect further issuance of permits for the importation of codeine as an active pharmaceutical ingredient for cough preparations.

The Minister of Health, Professor Isaac Adewole made this known in his office in Abuja on Tuesday, May 1, 2018.

He said that the directive became necessary due to the gross abuse Codeine usage has been subjected to in the country.

In its stead, the Minister said Codeine-containing cough syrups should be replaced with dextromethorphan which is less addictive.

He also directed the Pharmaceutical Council of Nigeria, (PCN) and NAFDAC to supervise the recall for labelling and audit trailing of all codeine-containing cough syrups in the country, while he has also banned sales of Codeine-containing cough syrup without prescription across the country.

He noted that the National Agency for Food and Drug Administration and Control had an emergency meeting with the Pharmaceutical Manufacturers Group (PMGMAN) to inform them that there is an embargo on all new applications for registration of codeine-containing cough syrups as well as applications for renewal has been abolished.

The Pharmacists Council of Nigeria (PCN) has been directed to continue enforcement activities at Pharmacies, Patent and Proprietary Medicine Vendor’s Shops and outlets throughout the country.

The National Agency for Food and Drug Administration and Control [NAFDAC] was also directed to fully carry out its functions among others: to regulate and control the manufacturing, distribution and sale of drugs, including inspection at points of entry of drugs, drug products and food for compliance with the new directive.

The Minister stated that the FMOH shall ensure collaboration among regulatory agencies namely, NAFDAC, PCN, National Drug Law Enforcement Agency (NDLEA), Nursing and Midwifery Council of Nigeria (NMCN), for effective implementation of extant Acts, regulations, policies and guidelines on codeine control and usage.

‘Furthermore, these agencies shall work together to increase pharmacovigilance around codeine, tramadol and other related substances of abuse,’ Adewole stated.

Already, NAFDAC has developed IEC materials that will be used in an already planned national campaign against drug abuse, an awareness programme that includes Young Pharmacists Group of the Pharmaceutical Society of Nigeria. This will soon be flagged off in Kano and Lagos.

As a way of discouraging youths to shun the drugs, the Federal Government through Federal Ministry of Health shall partner with National Orientation Agency (NOA), Nigeria Football Federation (NFF), Football celebrities, members of the Actors Guild of Nigeria, Performing Musicians of Nigeria and other celebrities to drive national campaign against drug abuse.

‘The FMOH shall ensure that Drug treatment intervention for victims of substances abuse shall be undertaken across the spectrum of healthcare delivery system in the country,’ Adewole stated.
He stated that Civil Society Organizations shall be strengthened to deliver effective sensitization, prevention, treatment and rehabilitation services.

Recalled that in view of the serious public health concerns drugs abuse poses to Nigerians, a working group which comprised of experts from various Ministries, Agencies of Government (including regulatory agencies), Development Partners and Associations was constituted in January and tagged Codeine Control and other Related Matters Working Group (CCRWG).

The CCRWG was formally inaugurated on January 23, 2018, with clear Terms of Reference of developing key recommendations and strategies to address the menace of codeine, tramadol and other related substances in Nigeria.

The CCRWG submitted its interim report on April 12, 2018, and recommended short-, medium- and long-term measures for implementation in a memorandum submitted to the Minister, today, 1st of May 2018.

Finally, Professor Adewole restated the commitment of FGN to ensure the full implementation of the National Drug Distribution Guideline (NDDG) by January 01, 2019 and closure of all open drug markets penultimate the implementation date of the NDDG that is, December 31, 2018. It is a public knowledge that easy access to codeine, tramadol and other substances of abuse is promoted by the chaotic drug distribution system.      (New Telegraph)

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